Innovent has posted another psoriasis win for its IL-23 contender to the likes of Tremfya and Skyrizi while the company awaits an approval decision by Chinese regulators.
The anti-IL-23 monoclonal antibody, called picankibart, was shown to clear or nearly clear all lesions after 16 weeks among 48.2% of the 82 participating Chinese patients that were classified as having psoriasis that had not been adequately treated by approved IL-17 or TNF-α inhibitors. This hit the primary endpoint of the phase 2 study.
The trial recruited a total of 152 patients, all of whom received a 200-mg dose of subcutaneous picankibart and then either the same dose every 12 weeks until Week 32 or a dose every four weeks for eight weeks before moving to 12-week intervals.
The company claimed that unlike “studies of other similar agents,” this trial was “more stringent” as the primary endpoint was not only the proportion of patients achieving a Physician's Global Assessment score of 0 or 1 but also a body surface area affected by psoriasis of less than 3%.
Following these “very encouraging” data, the company will move toward a phase 3 study looking at psoriasis therapy switchers, Innovent Senior Vice President of Clinical Development Lei Qian, M.D., Ph.D., said in an Oct. 29 release.
“With the widespread use of biological agents, the issue of inadequate response with these drugs has gradually become more prominent in clinical practice and urgently needs to be addressed,” Qian added. “This study shows that picankibart offers substantial skin clearance benefits even for patients with a inadequate response to other biologics (primarily anti-IL-17 agents).”
Chinese regulators are currently mulling an approval application for picankibart off the back of a successful phase 3 trial of 500 patients with moderate to severe plaque psoriasis.
Picankibart is designed to be given less frequently than some rivals. While the FDA has already approved antibodies in the U.S. against the IL23p19 subunit—with Sun Pharma’s Ilumya joining Johnson & Johnson’s Tremfya and AbbVie’s Skyrizi among the authorized products—Innovent sees value in developing an extended half-life treatment that can be dosed less frequently.
J&J has another IL-23 psoriasis option in the works courtesy of an IL-23R antagonist peptide called JNJ-2113. The Protagonist Therapeutics-partnered candidate fell short of the high bar set by injectable treatments in a phase 2 trial last year, but the convenience of oral delivery means the companies have still pushed the asset into phase 3.
As well as the successful phase 3 study behind the push for approval in China, Innovent is also evaluating picankibart in another late-stage psoriasis trial and a phase 2 study in patients with moderate to severe active ulcerative colitis.